CANNABIDIOL | N210365 | JAZZ PHARMACEUTICALS RESEARCH UK LTD
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
JAZZ PHARMACEUTICALS RESEARCH UK LIMITED v. TEVA PHARMACEUTICALS, INC. et al 1 patentANDA 217508, 217699, 215865, 217522, 217871, 217977, 217930, 217994, 217911, 217910cannabidiol | D.N.J. | 2023-07-21 | Terminated 2025-02-06 | — |
JAZZ PHARMACEUTICALS RESEARCH UK LIMITED v. TEVA PHARMACEUTICALS, INC. et al 25 patentsANDA 217508, 217699, 215865, 217522, 217871, 217977, 217930, 217994, 217911, 217910cannabidiol | D.N.J. | 2023-01-03 | Terminated 2025-02-06 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Daniel Fabricant, Ph.D. on behalf of Natural Products ... FDA-2022-P-0600 · 7 docket documents Daniel Fabricant, Ph.D., on behalf of the Natural Products Association, filed this citizen petition under 21 U.S.C. §321(ff) requesting that the FDA Commissioner determine that cannabidiol (CBD) is not excluded from the definition of a dietary supplement under the Dietary Supplement Health and Educa | Other | 2022-04-15 | Denied | Natural Products Association |
Citizen Petition from The Council for Responsible Nutrition FDA-2020-P-1582 · 4 docket documents The Council for Responsible Nutrition filed this citizen petition on June 16, 2020, requesting that the FDA exercise its regulatory authority under 21 U.S.C. § 321(ff)(3)(B) to establish a regulation allowing hemp-derived cannabidiol (CBD) to be legally marketed as a dietary supplement ingredient, c | Other | 2020-06-17 | Denied | The Council for Responsible Nutrition |
Citizen Petition from Consumer Healthcare Products Association FDA-2019-P-5394 · 4 docket documents The Consumer Healthcare Products Association filed this citizen petition on November 14, 2019, requesting that the FDA issue a regulation finding hemp-derived cannabidiol (CBD) lawful under the Federal Food, Drug and Cosmetic Act to establish a regulatory pathway for marketing CBD-containing dietary | Other | 2019-11-14 | Partially Denied | Consumer Healthcare Products Association |
Citizen Petition from Ascend Laboratories, LLC FDA-2018-P-4590 · 3 docket documents Ascend Laboratories, LLC filed this citizen petition requesting that the FDA/DEA assign Schedule V classification to cannabidiol oral solution 100 mg/mL manufactured synthetically, citing that synthetic CBD would have reduced tetrahydrocannabinol content compared to the naturally derived reference l | 505(q) | 2018-12-03 | Open | Ascend Laboratories, LLC |
Source: Regulations.gov. FDA citizen petitions matched by application number.
| Patent # | Expiration | PED | Drug Substance | Drug Product | Use Code | Delist |
|---|---|---|---|---|---|---|
| 9949937 | Jun 17, 2035 | — | — | — | — | |
| 9956183 | Jun 17, 2035 | — | — | — | — | |
| 9956184 | Jun 17, 2035 | — | — | — | — | |
| 9956185 | Jun 17, 2035 | — | — | — | — | |
| 9956186 | Jun 17, 2035 | — | — | — | — | |
| 10092525 | Jun 17, 2035 | — | — | — | — | |
| 10111840 | Jun 17, 2035 | — | — | — | — | |
| 10137095 | Jun 17, 2035 | — | — | — | — | |
| 10603288 | Jun 17, 2035 | — | — | — | — | |
| 10709671 | Jun 17, 2035 | — | — | — | — | |
| 10709673 | Jun 17, 2035 | — | — | Yes | — | — |
| 10709674 | Jun 17, 2035 | — | — | — | — | |
| 10849860 | Jun 17, 2035 | — | — | — | — | |
| 10918608 | Oct 13, 2035 | — | — | — | — | |
| 10966939 | Jun 17, 2035 | — | — | Yes | — | |
| 11065209 | Oct 13, 2035 | — | — | — | — | |
| 11096905 | Oct 13, 2035 | — | Yes | Yes | — | |
| 11154516 | Jun 17, 2035 | — | — | — | — | |
| 11160795 | Mar 1, 2041 | — | — | — | — | |
| 11207292 | Apr 26, 2039 | — | Yes | — | — | |
| 11311498 | Jun 17, 2035 | — | — | — | — | |
| 11357741 | Jun 17, 2035 | — | — | — | — | |
| 11400055 | Oct 13, 2035 | — | — | — | — | |
| 11406623 | Mar 1, 2041 | — | — | — | — | |
| 11446258 | Jun 17, 2035 | — | — | — | — | |
| 11633369 | Jun 17, 2035 | — | — | Yes | — | |
| 11701330 | Jun 17, 2035 | — | — | — | — | |
| 11766411 | Jun 17, 2035 | — | — | — | — | |
| 11865102 | Apr 26, 2039 | — | Yes | Yes | — | |
| 11963937 | Jun 17, 2035 | — | — | — | — | |
| 12064399 | Jun 17, 2035 | — | — | — | — | |
| 12102619 | Mar 1, 2041 | — | — | — | — | |
| 12661365Newly listed — daily FDA feed, not yet in monthly Orange Book edition | Sep 24, 2042 | — | — | — | — |
| Code | Date | Status |
|---|---|---|
| M-270 | Oct 20, 2026 | < 1 year |
| ODE-326 | Jul 31, 2027 | Active |
| ODE-332 | Jul 31, 2027 | Active |